DRKS00032613招募中Unknown
Surgery as needed versus surgery on principle in patients with postneoadjuvant clinical complete tumor response of esophageal cancer - ESORES-Trial
niversitätsklinikum Schleswig-Holstein, Campus Lübeck0 个研究点目标入组 670 人开始时间: 2023年9月27日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 670
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Key inclusion criteria:
- •EC (adenocarcinoma (EAC) and squamous cell carcinoma (ESCC)) according to the UICC definition (TNM8),
- •TNM stage: ycT0-3 ycN0 ycM0,
- •completion of neoadjuvant chemotherapy or neoadjuvant chemoradiation
- •no visible lymphatic or distant metastasis in routine postneoadjuvant CT,
- •ECOG Performance status 0-2
- •Age = 18 years
排除标准
- •Key exclusion criteria:
- •Postneoadjuvant dysphagia
- •Tumors of the cervical esophagus
- •Tumors with direct proximity to the membranous part of the central airway
- •TNM stage cT4 or ycT4
- •TNM stage cM1 or ycM1
- •Postneoadjuvant esophageal obstruction
- •Local tumor progression during/after neoadjuvant therapy detected by endoscopy or cross-sectional imaging
- •Time since last day of neoadjuvant anti-cancer treatment
- •Co-morbidity with contraindication for major surgery
- •nCRT with >50 Gy radiation dose
研究者
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